K253771 is an FDA 510(k) clearance for the Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13). This device is classified as a System, Ablation, Microwave And Accessories (Class II - Special Controls, product code NEY).
Submitted by Nanjing Devin Medical Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 2, 2026, 96 days after receiving the submission on November 26, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K253771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2025 |
| Decision Date | March 02, 2026 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEY — System, Ablation, Microwave And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |